US10646649B2 - Infusion devices and fluid identification apparatuses and methods - Google Patents

Abstract

Medical devices and methods and apparatuses for identifying fluids in a conduit of a device are provided. An exemplary apparatus for identifying an infusate in a conduit of an infusion device includes a transmitter element for transmitting a beam of energy for interaction with the infusate. Further, the apparatus includes a receiver element for receiving a signal from the beam of energy after interaction with the infusate. Also, the apparatus includes an identifier element coupled to the receiver element for analyzing the signal to identify the infusate. The transmitter element and receiver element may form a spectroscopy device and may transmit and receive a beam of infrared light or near infrared light.

Description

TECHNICAL FIELD

Embodiments of the subject matter described herein relate generally to medical devices, and more particularly, embodiments of the subject matter relate to the identification of fluids for delivery from infusion devices.

BACKGROUND

Infusion pump devices and systems are relatively well known in the medical arts, for use in delivering or dispensing a fluid agent or infusate, such as insulin or another prescribed medication, to a patient. A typical infusion pump includes a pump drive system which typically includes a small motor and drive train components that convert rotational motor motion to a translational displacement of a plunger (or stopper) in a reservoir that delivers medication from the reservoir to the body of a user via a fluid path created between the reservoir and the body of a user. Use of infusion pump therapy has been increasing, especially for delivering insulin for diabetics.

In practice, it is desirable to facilitate preparation of infusate for delivery to a patient or user. Specifically, there is a desire to make the process of preparing the infusate quicker. Typically, a user must use a syringe to withdraw the fluid agent from a larger receptacle and fill a device reservoir. Then, the user must ensure that there are no bubbles or other foreign matter in the device reservoir before coupling the device reservoir with the infusion pump device.

Thus, there is a desire to utilize pre-filled and packaged reservoirs or cartridges with infusion pump devices. Such reservoirs may be filled and packaged in an automated system and shipped to users for convenient use. However, with pre-filled and packaged reservoirs, there is a danger that a user may couple to the infusion pump device an infusate that is different from the infusate that is intended to be delivered. For example, the pre-filled and packaged reservoir may contain a different medication than the intended infusate, or may include the correct medication but in a different concentration than intended. In either case, the delivery of an incorrect infusate may cause severe injury or death to the patient.

Accordingly, there is a need to accurately identify the infusate for delivery from infusion devices. Further, there is a need to provide an automated apparatus and method for examining a fluid in an infusion device that satisfies the various requirements that may be imposed.

BRIEF SUMMARY

Medical devices and methods and apparatuses for identifying fluids in a conduit of a device are provided. An embodiment of an apparatus for identifying an infusate in a conduit of an infusion device includes a transmitter element for transmitting a beam of energy for interaction with the infusate. Further, the apparatus includes a receiver element for receiving a signal from the beam of energy after interaction with the infusate. Also, the apparatus includes an identifier element coupled to the receiver element for analyzing the signal to identify the infusate. The transmitter element and receiver element may form a spectroscopy device and may transmit and receive a beam of infrared light or near infrared light.

In another embodiment, a medical device includes a reservoir for holding a fluid and a conduit for dispensing the fluid from the reservoir. Further, the medical device includes a spectroscopy device for examining the fluid.

Another embodiment provides a method for identifying a fluid for delivery to a body of a user. The method includes transmitting a beam of energy into contact with the fluid. Also, the method includes receiving a signal from the beam of energy after interaction with the fluid. Further, the method includes analyzing the signal to identify the fluid.

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter may be derived by referring to the detailed description and claims when considered in conjunction with the following figures, wherein like reference numbers refer to similar elements throughout the figures, which may be illustrated for simplicity and clarity and are not necessarily drawn to scale.

FIG. 1 depicts an infusion media delivery system for use by a patient in accordance with an embodiment herein;

FIG. 2 depicts a plan view of an exemplary embodiment of a fluid infusion device suitable for use in the infusion system ofFIG. 1;

FIG. 3 depicts a plan view of an exemplary embodiment of another fluid infusion device suitable for use in the infusion system ofFIG. 1;

FIG. 4 depicts a plan view of an exemplary embodiment of an apparatus for examining a fluid in the fluid infusion device ofFIG. 2 or 3;

FIG. 5 depicts a plan view of another exemplary embodiment of an apparatus for examining a fluid in the fluid infusion device;

FIGS. 6-10 depict schematic diagrams of the operation of the apparatus for examining a fluid ofFIG. 4 or 5 in accordance with embodiments herein; and

FIG. 11 is a flow chart illustrating a method for identifying a fluid for delivery in accordance with an embodiment; and

FIG. 12 is an overlapped reflective NIR/IR spectra graph of fluid-path materials and infusates.

DETAILED DESCRIPTION

The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and uses of such embodiments. As used herein, the word “exemplary” means “serving as an example, instance, or illustration.” Any implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

While the subject matter described herein can be implemented in any electronic device, exemplary embodiments described below are implemented in the form of medical devices, such as portable electronic medical devices. Although many different applications are possible, the following description focuses on a fluid infusion device (or infusion pump) as part of an infusion system deployment. For the sake of brevity, conventional techniques related to infusion system operation, insulin pump and/or infusion set operation, and other functional aspects of the systems (and the individual operating components of the systems) may not be described in detail here. Examples of infusion pumps may be of the type described in, but not limited to, U.S. Pat. Nos. 4,562,751; 4,685,903; 5,080,653; 5,505,709; 5,097,122; 6,485,465; 6,554,798; 6,558,320; 6,558,351; 6,641,533; 6,659,980; 6,752,787; 6,817,990; 6,932,584; and 7,621,893; each of which are herein incorporated by reference.

Embodiments of the subject matter described herein generally relate to infusion systems including a fluid infusion device having an apparatus for identifying the infusate or infusion media that is prepared for delivery to the user or patient. Embodiments provide for automated examination of the infusate to ensure that the proper infusate and the proper concentration of the infusate are coupled to the fluid infusion device. In exemplary embodiments, a transmitter and receiver pair or a combined transmitter and receiver, i.e., transceiver, is utilized to direct a beam of energy at the infusate. The beam of energy contacts and interacts with matter in the beam path and absorptive and/or reflectance spectroscopy analysis may be used to identify that material by analyzing the energy transfer between the beam of energy and the matter.

The beam of energy may be in the ultraviolet (UV), near-infrared (NIR), or infrared (IR) energy range. Radiation referred to as ultraviolet defines the wavelength of from 10 nm to 400 nm while radiation referred to as near-infrared and infrared defines the wavelength range of from about 0.8 to about 25 um. Molecules can absorb such energy without later remission by exciting certain vibrational frequencies. Molecules absorb the frequencies of polychromatic light that correspond to its molecular vibrational transitions.

The energy interacts with the fluid, i.e., the energy is absorbed, refracted and/or reflected by the fluid, and with undesired bubbles or foreign matter, such as fibrils, in the fluid. Therefore, the beam is altered by the fluid and by any undesired bubbles or foreign matter therein. The altered beam may be considered to be a signal indicative of the media through which the energy passed or from which the energy was reflected. In an exemplary embodiment, the signal is captured by the receiver and is analyzed. Analysis of the signal reveals whether the proper infusate and the proper concentration of the infusate are coupled to the fluid infusion device. For example, a spectrum of frequencies or wavelengths of the signal may be compared to known spectra of frequencies or wavelengths of medications at specific concentrations, air bubbles, or foreign materials to identify the analyzed infusate, and to identify whether air or foreign matter is present in the analyzed infusate. In an exemplary embodiment, the signal analyzed by the receiver is may be an electric or intensity reading at one or more wavelengths or may be a spectra over any selected wavelength range, such as from about 0.2 to about 16 μm.

Using UV/NIR/IR spectroscopy allows for differentiation of liquid infusate compositions from the polymeric materials used in the fluid delivery device, i.e., the polypropylene reservoir, polycarbonate cap, and polyurethane/polypropylene tubing. Thus, the liquid infusate may be spectroscopically analyzed and compared to other previously tested compositions and concentrations to identify the analyzed infusate.

The disclosure relates generally to delivery devices, systems and methods for delivering infusate or infusion media, such as a drug, to a recipient, such as a medical patient. In particular embodiments, a delivery device includes a disposable portion that secures to the recipient and that may be readily disposed of after it has been in use for a period of time. Such embodiments may be configured to provide a reliable, user-friendly mechanism to secure the delivery device to a patient for delivery of fluidic infusion media to the patient. Embodiments may be configured with feature that enhance the ease by which patients may secure the delivery device to the patient's skin and further features that enhance the ease by which patients may fill, re-fill or replace spent infusion media.

While embodiments are described herein with reference to an insulin delivery example for treating diabetes, other embodiments may be employed for delivering other infusion media to a patient for other purposes. For example, further embodiments may be employed for delivering other types of drugs to treat diseases or medical conditions other than diabetes, including, but not limited to drugs for treating pain or certain types of cancers, pulmonary disorders or HIV. Thus, the infusate may be insulin, HIV drugs, drugs to treat pulmonary hypertension, iron chelation drugs, pain medications, anti-cancer treatments, medications, vitamins, hormones, or the like. Further embodiments may be employed for delivering media other than drugs, including, but not limited to, nutritional media including nutritional supplements, dyes or other tracing media, saline or other hydration media, or the like.

A generalized representation of an infusionmedia delivery system10 is shown inFIG. 1, wherein the system includes an infusion ordelivery device12 configured according to embodiments described herein. In the illustrated embodiment ofFIG. 1, thedelivery device12 is designed as a portable medical device suitable for infusing an infusate, i.e., a fluid, a liquid, a gel, or other agent, into the body of a user.

The infusionmedia delivery system10 may also include other components coupled for communication with thedelivery device12, including, but not limited to, asensing arrangement14 such as a sensor or monitor, a command control device (CCD)16, and acomputer18. Each of theCCD16, thecomputer18 and thedelivery device12 may include receiver or transceiver electronics that allow communication with other components of the system. Thedelivery device12 may include electronics and software for analyzing sensor data and for delivering infusion media according to sensed data and/or pre-programmed delivery routines. Some of the processing, delivery routine storage and control functions may be carried out by theCCD16 and/or thecomputer18, to allow thedelivery device12 to be made with more simplified electronics. However, in other embodiments, the infusionmedia delivery system10 may comprisedelivery device12 without any one or more of the other components of the infusionmedia delivery system10 shown inFIG. 1. The elements of the infusionmedia delivery system10 may be similar to those described in U.S. Pat. No. 8,674,288, the subject matter of which is hereby incorporated by reference in its entirety.

In the generalized system diagram ofFIG. 1, thedelivery device12 and sensor or monitor14 are secured to a patient-user. The locations at which those components are secured to the patient-user inFIG. 1 are provided only as a representative, non-limiting example. Thedelivery device12 and sensor or monitor14 may be secured at other locations on the patient, and such locations may depend upon the type of treatment to be administered by the infusionmedia delivery system10. As described in further detail below, thedelivery device12 contains a reservoir of infusate or infusion media and delivers the infusate into the patient's body in a controlled manner.

Thesensing arrangement14 generally represents the components of the fluid delivery or infusionmedia delivery system10 configured to sense, detect, measure or otherwise quantify a condition of the user, and may include a sensor, a monitor, or the like, for providing data indicative of the condition that is sensed, detected, measured or otherwise monitored by the sensing arrangement. In this regard, thesensing arrangement14 may include electronics and enzymes reactive to a biological or physiological condition of the user, such as a blood glucose level, or the like, and provide data indicative of the blood glucose level to theinfusion device12, theCCD16 and/or thecomputer18. For example, theinfusion device12, theCCD16 and/or thecomputer18 may include a display for presenting information or data to the user based on the sensor data received from thesensing arrangement14, such as, for example, a current glucose level of the user, a graph or chart of the user's glucose level versus time, device status indicators, alert messages, or the like. In other embodiments, theinfusion device12, theCCD16 and/or thecomputer18 may include electronics and software that are configured to analyze sensor data and operate theinfusion device12 to deliver fluid to the body of the user based on the sensor data and/or preprogrammed delivery routines. Thus, in exemplary embodiments, one or more of theinfusion device12, thesensing arrangement14, theCCD16, and/or thecomputer18 includes a transmitter, a receiver, and/or other transceiver electronics that allow for communication with other components of the infusionmedia delivery system10, so that thesensing arrangement14 may transmit sensor data or monitor data to one or more of theinfusion device12, theCCD16 and/or thecomputer18.

Still referring toFIG. 1, in various embodiments, thesensing arrangement14 may be secured to the body of the user or embedded in the body of the user at a location that is remote from the location at which theinfusion device12 is secured to the body of the user. In various other embodiments, thesensing arrangement14 may be incorporated within theinfusion device12. In other embodiments, thesensing arrangement14 may be separate and apart from theinfusion device12, and may be, for example, part of theCCD16. In such embodiments, thesensing arrangement14 may be configured to receive a biological sample, analyte, or the like, to measure a condition of the user.

In various embodiments, theCCD16 and/or thecomputer18 may include electronics and other components configured to perform processing, delivery routine storage, and to control theinfusion device12 in a manner that is influenced by sensor data measured by and/or received from thesensing arrangement14. By including control functions in theCCD16 and/or thecomputer18, theinfusion device12 may be made with more simplified electronics. However, in other embodiments, theinfusion device12 may include all control functions, and may operate without theCCD16 and/or thecomputer18. In various embodiments, theCCD16 may be a portable electronic device. In addition, in various embodiments, theinfusion device12 and/or thesensing arrangement14 may be configured to transmit data to theCCD16 and/or thecomputer18 for display or processing of the data by theCCD16 and/or thecomputer18.

In some embodiments, theCCD16 and/or thecomputer18 may provide information to the user that facilitates the user's subsequent use of theinfusion device12. For example, theCCD16 may provide information to the user to allow the user to determine the rate or dose of medication to be administered into the user's body. In other embodiments, theCCD16 may provide information to theinfusion device12 to autonomously control the rate or dose of medication administered into the body of the user. In some embodiments, thesensing arrangement14 may be integrated into theCCD16. Such embodiments may allow the user to monitor a condition by providing, for example, a sample of his or her blood to thesensing arrangement14 to assess his or her condition. In some embodiments, thesensing arrangement14 and theCCD16 may be used for determining glucose levels in the blood and/or body fluids of the user without the use of, or necessity of, a wire or cable connection between theinfusion device12 and thesensing arrangement14 and/or theCCD16.

In one or more exemplary embodiments, thesensing arrangement14 and/or theinfusion device12 are cooperatively configured to utilize a closed-loop system for delivering fluid to the user. Examples of sensing devices and/or infusion pumps utilizing closed-loop systems may be found at, but are not limited to, the following U.S. Pat. Nos. 6,088,608, 6,119,028, 6,589,229, 6,740,072, 6,827,702, 7,323,142, and 7,402,153, all of which are incorporated herein by reference in their entirety. In such embodiments, thesensing arrangement14 is configured to sense or measure a condition of the user, such as, blood glucose level or the like. Theinfusion device12 is configured to deliver fluid in response to the condition sensed by thesensing arrangement14. In turn, thesensing arrangement14 continues to sense or otherwise quantify a current condition of the user, thereby allowing theinfusion device12 to deliver fluid continuously in response to the condition currently (or most recently) sensed by thesensing arrangement14 indefinitely. In some embodiments, thesensing arrangement14 and/or theinfusion device12 may be configured to utilize the closed-loop system only for a portion of the day, for example only when the user is asleep or awake.

An example of a patch-like delivery device12 according to an embodiment is shown inFIG. 2. Thedelivery device12 inFIG. 2 includes adisposable portion20 and adurable portion22. Thedisposable portion20 may include structural elements that ordinarily contact the patient's skin or infusion media, during operation of thedelivery device12. On the other hand, thedurable portion22 may have elements (including electronics, motor components, linkage components, and the like) that do not ordinarily contact the patient or infusion media during operation of thedelivery device12. Thus, elements in thedurable portion22 of thedelivery device12 are typically not contaminated from contact with the patient or infusion media during normal operation of thedelivery device12.

In the illustrated embodiment, the disposable portion of thedelivery device12 comprises adisposable base portion20 that supports areservoir24. Thedurable portion22 may comprise a housing that secures onto thebase portion20 and covers thereservoir24. Thedurable portion22 may house a suitable drive device, such as an electrically operated motor (not shown inFIG. 2), and drive linkage components (not shown inFIG. 2) for driving fluid out of thereservoir24. Thedurable portion22 also may house suitable control electronics (not shown inFIG. 2) for controlling the operation of the drive device to drive fluid from thereservoir24 in a controlled manner. Further embodiments may include communication electronics (not shown inFIG. 2) within thedurable portion22, for communicating with the sensor or monitor14, theCCD16, thecomputer18 and/or other components of the infusionmedia delivery system10.

Thedisposable base portion20 has a bottom surface (facing downward and into the page inFIG. 2) that is configured to secure to a patient's skin at a desired location on the patient. A suitable adhesive may be employed at the interface between the bottom surface of thebase portion20 and the patient's skin, to adhere thebase portion20 to the patient's skin. The adhesive may be provided on the bottom surface of thebase portion20, with a removable cover layer covering the adhesive material. In this manner, a patient-user may peel off the cover layer to expose the adhesive material and then place the adhesive side of thebase portion20 against the patient's skin.

Thebase portion20 may include a suitable opening orport23 for connecting ahollow tube25 to thereservoir24, to convey infusion media from thereservoir24. One end of thetube25 may have asuitable connector26, such as, but not limited to a Luer connector or a threaded cap connector having a hollow needle for coupling (in fluid-flow communication) to a correspondingconnector27 on thereservoir24. Alternatively or in addition, thereservoir24 may include a septum as part of theconnector27, for receiving an end of a hollow needle. The opening or port on thebase portion20 may be provided with corresponding connector structure, such as, but not limited to a Luer connector receptacle or a threaded receptacle shaped to receive a threaded cap connector. Other embodiments may employ other suitable connectors or connection arrangements for connecting one end of thetube25 in fluid-flow communication with thereservoir24.

The other end of thetube25 may connected to ahollow needle21 for piercing the patient's skin and conveying infusion media into the patient. Thehollow needle21 may be secured to the patient's skin, for example, by manual application or with the assistance of an insertion tool, such as, but not limited to the insertion tool described in U.S. Patent Application Publication No. 2002/0022855, titled “Insertion Device For An Insertion Set And Method Of Using The Same.” In other embodiments, as described below, a hollow needle and insertion mechanism may be included within thedelivery device12, so as to avoid the need for aport23,tube25 andconnector26.

Thedurable portion22 of thedelivery device12 includes a housing shell configured to mate with and secure to thedisposable base portion20. Thedurable portion22 andbase portion20 may be provided with correspondingly shaped grooves, notches, tabs or other suitable features that allow the two parts to easily snap together, by manually pressing the two portions together in a manner well known in the mechanical arts. In a similar manner, thedurable portion22 andbase portion20 may be separated from each other by manually applying sufficient force to unsnap the two parts from each other. In further embodiments, a suitable seal, such as an o-ring seal, may be placed along the peripheral edge of thebase portion20 and/or thedurable portion22, so as to provide a seal against water between thebase portion20 and thedurable portion22.

Thedurable portion22 andbase portion20 may be made of suitably rigid materials that maintain their shape, yet provide sufficient flexibility and resilience to effectively snap together and apart, as described above. Thebase portion20 material may be selected for suitable compatibility with the patient's skin. For example, thebase portion20 and thedurable portion22 of thedelivery device12 may be made of any suitable plastic, metal, composite material or the like. Thebase portion20 may be made of the same type of material or a different material relative to thedurable portion22. The base portion and durable portions may be manufactured by injection molding or other molding processes, machining processes or combinations thereof.

For example, thebase portion20 may be made of a relatively flexible material, such as a flexible silicon, plastic, rubber, synthetic rubber or the like. By forming the base portion of a material capable of flexing with the patient's skin, a greater level of patient comfort may be achieved when the base portion is secured to the patient's skin. Also, aflexible base portion20 can result in an increase in the site options on the patient's body at which thebase portion20 may be secured.

In the embodiment illustrated inFIG. 2, thedurable portion22 of thedelivery device12 is connected tosensor14, through asensor lead29.Sensor14 may comprise any suitable biological or environmental sensing device, depending upon the nature of the treatment to be administered by thedelivery device12. For example, in the context of delivering insulin to a diabetes patient, thesensor14 may comprise a blood glucose sensor.

Thesensor14 may be an external sensor that secures to the patient's skin or, in other embodiments, may be an implantable sensor that is located in an implant site within the patient. In the illustrated example ofFIG. 2, thesensor14 is an external sensor having adisposable needle pad14′ that includes a needle for piercing the patient's skin and enzymes and/or electronics reactive to a biological condition, such as blood glucose level, of the patient. Thedisposable needle pad14′ may electrically contact electrical conductors in thelead29, to convey electrical signals from thesensor14 to suitable sensor electronics located within thedurable portion22 of thedelivery device12. Thelead29 may have any suitable length. In this manner, thedelivery device12 may be provided with sensor data from a sensor secured to the patient, at a site remote from the location at which thedelivery device12 is secured to the patient.

While the embodiment shown inFIG. 2 includes asensor14 connected by alead29 for providing sensor data to sensor electronics located within thedurable portion22 of thedelivery device12, other embodiments may employ asensor14 located within thedelivery device12. Yet other embodiments may employ asensor14 having a transmitter for communicating sensor data by a wireless communication link with to receiver electronics located within thedurable portion22 of thedelivery device12. The wireless connection between thesensor14 and the receiver electronics in thedurable portion22 of thedelivery device12 may comprise a radio frequency RF connection, an optical connection, or another wireless suitable communication link. Further embodiments need not employ a sensor and, instead, provide infusion media delivery functions without the use of sensor data.

As described above, by separating disposable elements of thedelivery device12 from durable elements, the disposable elements may be arranged on thedisposable base portion20, while durable elements may be arranged within a separabledurable portion22. In this regard, after one (or a prescribed number) of uses of thedelivery device12, thedisposable base portion20 may be separated from thedurable portion22, so that thedisposable base portion20 may be disposed of in a proper manner. Thedurable portion22 may, then, be mated with a new (un-used)disposable base portion20 for further delivery operation with a patient.

Thereservoir24 may be supported by thedisposable base portion20 in any suitable manner. Thereservoir24 may be provided as a cartridge or generally cylindrical canister for containing fluidic infusion media. For example, thebase portion20 may be provided with projections or struts, or a trough feature for holding a cartridge-type reservoir in a manner that allows a user to readily remove the reservoir from the base portion and re-install a new or refilled reservoir, when replacement or re-filling is needed, as described with respect to further embodiments below. Alternatively, or in addition, thereservoir24 may be secured to thebase portion20 by a suitable adhesive or other coupling structure. Thereservoir24 has a port and may be supported by thebase portion20 in a position at which aconnector26 may engage or otherwise come into fluid flow communication with the reservoir port, when theconnector26 is connected to theport23 on thebase portion20.

Thedurable portion22 of thedelivery device12 may include a motor or other force-applying mechanism, for applying a force to the infusion media within thereservoir24 to force fluidic infusion media out of thereservoir24 and into the needle, for delivery to the patient. For example, an electrically driven motor may be mounted within thedurable portion22 with appropriate linkage for causing the motor to operably engage a piston of the reservoir and drive the reservoir piston in a direction to cause the fluidic pressure within thereservoir24 to increase and thereby force fluidic infusion media out of the reservoir port, into thetube25 and needle. The motor may be arranged within thedurable portion22 and the reservoir may be correspondingly arranged on thedisposable portion20, such that the operable engagement of the motor with the reservoir piston (e.g., through appropriate linkage) occurs automatically upon the patient-user snap fitting thedurable portion22 onto thedisposable portion20 of thedelivery device12.

WhileFIG. 2 illustrates an embodiment of a patch-like delivery device12 for use in thefluid delivery system10,FIG. 3 illustrates an exemplary embodiment of a fluidinfusion delivery device12 coupled with an infusion set104 with a fluid conduit assembly for use in thefluid delivery system10 ofFIG. 1. The fluidinfusion delivery device12 accommodates a fluid reservoir (hidden from view inFIG. 3) for the infusate to be delivered to the user.

The illustrated embodiment of the infusion set104 includes, without limitation: a length oftubing110; aninfusion unit112 coupled to the distal end of thetubing110; and aconnector114 coupled to the proximal end of thetubing110. The fluidinfusion delivery device12 is designed to be carried or worn by the patient, and the infusion set104 terminates at theinfusion unit112 such that the fluidinfusion delivery device12 can deliver fluid to the body of the patient via thetubing110. Theinfusion unit112 includes a cannula (hidden from view inFIG. 3) that is coupled to the distal end of thetubing110. The cannula is inserted into the skin and is held in place during use of the fluidinfusion delivery device12.

The infusion set104 defines a fluid flow path that couples a fluid reservoir to theinfusion unit112. Theconnector114 mates with and couples to a section of the fluid reservoir (not shown), which in turn is coupled to ahousing120 of the fluidinfusion delivery device12. Theconnector114 establishes the fluid path from the fluid reservoir to thetubing110. Actuation of the fluidinfusion delivery device12 causes the medication fluid to be expelled from the fluid reservoir, through the infusion set104, and into the body of the patient via theinfusion unit112 and cannula at the distal end of thetubing110. Accordingly, when theconnector114 is installed as depicted inFIG. 3, thetubing110 extends from the fluidinfusion delivery device12 to theinfusion unit112, which in turn provides a fluid pathway to the body of the patient.

The fluidinfusion delivery device12 includes a radio frequency (RF) antenna to support wireless data communication with other devices, systems, and/or components. The RF antenna can be located inside thehousing120 or it can be integrally formed with thehousing120. Accordingly, the RF antenna is hidden from view inFIG. 3.

As may be understood fromFIGS. 1-3, each embodiment of thefluid delivery device12 includes a reservoir for holding an infusate and a fluid path for delivering the infusate from the reservoir to the patient. Other embodiments offluid delivery devices12 are contemplated herein for use with the infusate identifying apparatus and method. The reservoir and fluid path in suchfluid delivery devices12 are considered to be portions of a conduit in which the infusate is contained and flows.FIGS. 4 and 5 illustrate embodiments in which a portion of thefluid delivery device12 is provided with an apparatus for identifying the infusate and any foreign matter within the infusate while located in the conduit.

InFIG. 4, an identifyingapparatus200 is located on or otherwise coupled to theconnector114 of the fluid delivery device ofFIG. 3. It is contemplated that the identifyingapparatus200 ofFIG. 4 may be utilized with other types of fluid delivery devices. As shown, theconnector114 defines afluid path210 in which the infusate may be contained and through which the infusate may flow. Fluid communication may be established between thefluid path210 and the reservoir (not shown) through a coupling orfitting215.

Thefluid path210 may be defined and bounded by awall220.Wall220 may be transparent, translucent, or otherwise transmit the interrogating beam of energy (described below). Anexemplary wall220 is substantially transparent. For example,wall220 may be formed from a transparent material such as clear polycarbonate, polypropylene, polyurethane/polypropylene, or other clear polymeric material. Alternatively or additionally, thewall220 of thefluid path210 may be formed with awindow225 that is transparent, translucent, or otherwise transmit the interrogating beam of energy. An exemplarytransparent window225 may be formed from clear polycarbonate, polypropylene, polyurethane/polypropylene, or other clear polymeric material.

As shown inFIG. 4, the identifyingapparatus200 includes atransmitter element230.Transmitter element230 may be a standalone transmitter or part of a transceiver device that transmits and receives. Anexemplary transmitter element230 is arranged to transmit a beam of energy into thefluid path210, either throughwall220 or through awindow225 inwall220, for interaction with an infusate contained within thefluid path210. Anexemplary transmitter element230 is an infrared (IR), near infrared (NIR) or ultraviolet (UV) emitter and is arranged to transmit a beam of IR, NIR or UV energy into thefluid path210. In an exemplary embodiment, the transmitter element transmits the beam of energy into the fluid orthogonally to the direction of fluid flow.

Further, the exemplary identifyingapparatus200 includes areceiver element235.Receiver element235 may be a standalone receiver or part of a transceiver device that transmits and receives. Anexemplary receiver element235 is arranged to receive a beam of energy from thefluid path210, either throughwall220 or through awindow225 inwall220. Anexemplary transmitter element230 is an infrared (IR), near infrared (NIR) or ultraviolet (UV) receiver and is arranged to receive a beam of IR, NIR or UV energy from thefluid path210.

As shown inFIG. 4, thereceiver element235 may be located on an opposite side of thefluid path210 from thetransmitter element230 to receive a signal, in the form of an altered beam of energy, that passes through thefluid path210. Alternatively, areceiver element235′ may be located on the same side of thefluid path210 as thetransmitter element230 to receive a signal, in the form of an altered beam of energy, that is reflected from thefluid path210. Thetransmitter element230 andreceiver element235 may be in wired or wireless electronic connection with receiver electronics that may communicate withsensing arrangement14,CCD16 orcomputer18 ofFIG. 1. The receiver electronics, sensingarrangement14,CCD16 orcomputer18 may include an identifier element for analyzing an electronic representation of the signal of the altered beam of energy received by areceiver element235.

The signal received by thereceiver element235 differs from the initial beam of energy transmitted by thetransmitter element230. Specifically, absorption and/or reflectance of radiation, as a function of frequency or wavelength, results from interaction of the beam of energy with the infusate and any foreign matter in the fluid path210 (as well as the window225). Therefore, the resulting beam or signal exiting thefluid path210 includes a lower radiation intensity, particularly at specific frequencies or wavelengths. The radiation spectrum of the signal exiting thefluid path210 provide a identifiable signature or fingerprint associated with the matter on which the beam was directed and may be used in analysis as described below. The electronic representation of the signal that is analyzed by the identifier element may include electric or intensity readings at one or more wavelengths or a spectra over an selected range of wavelengths, such as from 0.2 to 16 μm.

FIG. 5 illustrates an embodiment in which the identifyingapparatus200 is provided for use with afluid delivery device12 as illustrated inFIG. 2. InFIG. 5, thereservoir24 is shown as being mounted in thedurable portion22 of the delivery device. As shown, thereservoir24 includes aconnector27 for mating connection with the hollow tube as discussed above in relation toFIG. 2. As used herein, any of the components containing or delivering a flow of an infusate are considered a conduit.

InFIG. 5, awall220 bounds and defines thereservoir24. Thewall220 may be transparent, translucent, or otherwise transmit the interrogating beam of energy as described above in relation toFIG. 4. InFIG. 5, thewall220 is illustrated as includes awindow225 that is transparent to the intended type of interrogating beam energy and response signal energy.

Further, the fluid delivery device inFIG. 5 includes atransceiver240 that includes both a transmitter element and a receiver element. Thetransceiver240 is aligned with thewindow225 so that thetransceiver240 may transmit a beam of energy through thewindow225 and into contact with an infusate located in thereservoir24, and may receive a reflected beam of energy from the infusate and through thewindow225.

As further shown, thetransceiver240 is mounted to a printed circuit board (PCB)245 that may be part of receiver electronics located within thedurable portion22. ThePCB245 may be in communication withsensing arrangement14,CCD16 orcomputer18 ofFIG. 1 through the receiver electronics. ThePCB245 may serve as an identifier element for analyzing a signal received by a receiver element of thetransceiver240. Alternatively, thesensing arrangement14,CCD16 orcomputer18 may include an identifier element for analyzing a signal received by a receiver element of thetransceiver240. In either case, the identifier element may analyze an electronic representation of the signal that may include electric or intensity readings at one or more wavelengths or a spectra over an selected range of wavelengths, such as from 0.2 to 16 μm.

WhileFIG. 4 illustrates an embodiment in which the identifyingapparatus200 includes atransmitter element230 andreceiver element235 mounted to theconnector114 andFIG. 5 illustrates an embodiment in which the identifyingapparatus200 includes atransceiver240 that is mounted to adurable portion22, other embodiments are contemplated. For example, thetransmitter element230 andreceiver element235 may be physically decoupled from the conduit where analysis is to be performed. Also, theelements230 and235 may be mounted to thewall220 of the conduit where analysis is to be performed. Further,elements230 and235 may be located within the conduit where analysis is to be performed. Also,elements230 and235 could be formed as parts of other components within the fluid delivery device. As contemplated herein, the identifyingapparatus200, includingelements230 and235, may be located in any suitable location along the fluid path of afluid delivery device12. Further, afluid delivery device12 may be provided with more than one identifyingapparatus200, each includingelements230 and235. In an exemplary embodiment, each of the identifyingapparatuses200 transmits a beam of energy into the fluid orthogonally to the direction of fluid flow or to the wall of the vessel through which the fluid flows.

FIGS. 6-10 illustrate the use oftransmitter elements230 andreceiver elements235 of an identifying apparatus100 to identify the composition and concentration of a fluid orinfusate280 within aconduit260, such as a reservoir, hollow tube, or other fluid path, that is bound by awall220. In the embodiments ofFIGS. 6-10, thewall220 is transparent and does not include a separate distinct window as illustrated in the embodiments ofFIGS. 4-5. InFIGS. 6-10, a beam ofenergy300, such as IR, NIR, or UV energy, is transmitted into theconduit260 through thewall220 from afirst side301 of theconduit260. The beam ofenergy300 interacts with theinfusate280 and any foreign matter. For example, different portions or wavelength ranges of the beam ofenergy300 may be absorbed, refracted or reflected. In certain embodiments, a resulting beam of energy passes through theconduit260 and to the oppositesecond side302 of theconduit260. In other embodiments, a resulting beam of energy reflects from theconduit260 back to thefirst side301 of theconduit260.

Referring now toFIG. 6, an embodiment is illustrated in which atransmitter element230 is located on thefirst side301 of theconduit260 and thereceiver element235 is located on thesecond side302 of theconduit260. Thetransmitter element230 transmits a beam of energy through thewall220 and into theconduit260 into contact with theinfusate280. As described above, the beam ofenergy300 interacts with theinfusate280 and a resulting beam ofenergy310 passes through theconduit260 and exits to thesecond side302 of theconduit260. As shown, the resulting beam ofenergy310 is received byreceiver element235 as a signal. The signal can be analyzed as described below in relation toFIG. 11 to determine the composition and concentration of theinfusate280 and whether foreign matter is present in theinfusate280.

FIG. 7 illustrates an embodiment in which both thetransmitter element230 and thereceiver element235 are located on thefirst side301 of theconduit260. InFIG. 7, thetransmitter element230 transmits the beam ofenergy300 through thewall220 and into theconduit260 into contact with theinfusate280. The beam ofenergy300 interacts with theinfusate280 and a resulting beam ofenergy310 is reflected back out of the conduit and to thefirst side301 of theconduit260. As shown, the resulting beam ofenergy310 is received byreceiver element235 as a signal and can be analyzed as described below. It is contemplated that an embodiment may use both an oppositeside receiver element235 ofFIG. 6 and a sameside receiver element235 ofFIG. 7 for receiving the resulting beam ofenergy310.

FIG. 8 illustrates a similar structural arrangement asFIG. 7. However, inFIG. 8, it is contemplated that the beam ofenergy300 transmitted bytransmitter element230 is reflected by theinfusate280 at theinterface290 of theinfusate280 and thewall220. As shown, the reflected beam ofenergy310 passes back through thewall220 and is received by thereceiver element235 as a signal for analysis.

FIGS. 9 and 10 illustrate atransceiver240 including atransmitter element230 andreceiver element235. Necessarily, thetransmitter element230 andreceiver element235 are each located on thefirst side310 of theconduit260. InFIG. 9, thetransmitter element230 transmits the beam ofenergy300 through thewall220 and into theconduit260 into contact with theinfusate280. The beam ofenergy300 interacts with theinfusate280 and a resulting beam ofenergy310 is reflected back out of the conduit and to thefirst side301 of theconduit260. As shown, the resulting beam ofenergy310 is received byreceiver element235 as a signal for analysis.

FIG. 10 illustrates a similar structural arrangement asFIG. 9. InFIG. 10, it is contemplated that the beam ofenergy300 transmitted bytransmitter element230 is reflected by theinfusate280 at theinterface290 of theinfusate280 and thewall220. As shown, the reflected beam ofenergy310 passes back through thewall220 and is received by thereceiver element235 as a signal for analysis.

It is contemplated that an embodiment may use one or more arrangements oftransmitter elements230,receiver elements235, and/ortransceivers240 ofFIGS. 6-10, such as with both same side and oppositeside receiver elements235 for receiving the resulting beam ofenergy310.

After the signal of the resulting beam ofenergy310 is received by thereceiver element235 inFIGS. 6-10, analysis is performed to identify the composition of theinfusate280, the concentration of the infusate, and/or the presence of foreign matter in theinfusate280. For example, spectroscopic analysis may be performed and compared to a library of known spectral signatures.

FIG. 11 illustrates anexemplary method400 for identifying a fluid for delivery to a body of a user. As shown, an infusate reservoir or other container with a conduit holding an infusate is coupled to a fluid delivery device atstep402. Upon coupling, the identification process may be initiated to confirm that the correct infusate is loaded in the fluid delivery device. Alternatively, the identification process may be initiated when fluid is forced out of the reservoir and through a testing location elsewhere in the fluid conduit. For example, atstep404, a beam of energy is transmitted from the transmitter element into the conduit holding the infusate. The beam of energy interacts with the infusate and exits the conduit as a resulting beam of energy. As used herein, a beam of energy reflected at the interface of the conduit and wall bounding the conduit is considered to have passed through the wall and exits the conduit upon reflection with the interface. Atstep406, the resulting beam of energy is received by the receiver element.

Atstep408, the signal of the resulting beam of energy is communicated from the receiver element to an identifier element. For example, the signal may be wirelessly communicated from the receiver element to the identifier element. The identifier element may be contained within a PCB, sensing arrangement, CCD or computer. The signal is or includes spectroscopic data that may be represented by a spectrum that may be plotted as a graph of energy absorbance (or transmittance) on the vertical axis vs. frequency or wavelength on the horizontal axis.

The identifier element includes or is coupled to a memory storage or library of spectra of known, i.e., previously tested compositions and concentrations. The memory stores data associated with selected fluids for comparison with detected characteristics of the signal. Atstep410, the spectrum of the signal is compared to the spectra of known compositions and concentrations. For example, the identifier element may use the stored data to identify the infusate based on the received signal. As is known in absorptive spectroscopic analysis, different compositions and different concentrations of those compositions exhibit unique spectra or signature spectra. For example, differing values of intensity of radiation at specific wavelengths or frequencies or over specific ranges of wavelengths or frequencies may indicate that the beam of energy passed through a specific concentration of a specific composition. As an example, a reflective NIR/IR spectra graph of fluid-path materials and infusates (insulin formulations) is presented inFIG. 12, in which the spectral different regions may be used for infusate/bubble tracking. In the exemplary embodiment ofFIG. 12, reflective NIR/IR spectra of fluid-path materials and infusates indicate that there are two NIR regions (around 1.7 μm or around 3 μm) that may be used for infusate tracking inside the polymeric component (reservoir, p-cap, or tubing). Spectroscopic signals at various wavelengths may be orthogonally used for better identification accuracy.

Atstep412, the method queries whether, based on the signal spectrum comparison, the proper or expected infusate is loaded in the fluid delivery device. If not, the PCB, sensing arrangement, CCD or computer may automatically alert the user and/or disable infusion of the infusate from the fluid delivery device atstep414. On the other hand, if the correct infusate is loaded, the PCB, sensing arrangement, CCD or computer may confirm that the correct infusate is loaded and allow the fluid delivery device to proceed with an infusion process atstep416.

While the subject matter is described above primarily in the context of a pre-loaded reservoir containing insulin reservoir for regulating a glucose level of a user, the subject matter described herein is not limited to any type of media dispensed from or otherwise provided by the reservoir, and the subject matter may be implemented with other medical devices or electronic devices other than fluid infusion devices. For example, any electronic device could be configured to analyze and identify the composition and concentration of a fluid contained in a conduit through transmission of a beam of energy and processing of the resulting signal through spectroscopic analysis.

For the sake of brevity, conventional techniques related to glucose sensing and/or monitoring, closed-loop glucose control, sensor calibration, electrical signals and related processing, electrical interconnects or interfaces, packaging, fluid communications, fluid monitoring or measuring, and other functional aspects of the subject matter may not be described in detail herein. In addition, certain terminology may also be used in the herein for the purpose of reference only, and thus is not intended to be limiting. For example, terms such as “first”, “second”, and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context. The foregoing description may also refer to elements or nodes or features being “connected” or “coupled” together. As used herein, unless expressly stated otherwise, “coupled” means that one element/node/feature is directly or indirectly joined to (or directly or indirectly communicates with) another element/node/feature, and not necessarily mechanically.

While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. For example, the subject matter described herein is not necessarily limited to the infusion devices and related systems described herein. Moreover, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiment or embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope defined by the claims, which includes known equivalents and foreseeable equivalents at the time of filing this patent application. Accordingly, details of the exemplary embodiments or other limitations described above should not be read into the claims absent a clear intention to the contrary.

Claims (9)

What is claimed is:

1. A method for identifying a fluid for delivery to a body of a user, the method comprising:

holding a first fluid in a reservoir;

coupling the reservoir to a device housing having a conduit;

coupling the device housing to an infusion device with a connector, wherein the connector comprises:

a coupling directly connected to the reservoir to establish fluid communication from the reservoir to the conduit;

a wall having an internal surface and an external surface, wherein the internal surface bounds the conduit;

a transmitter element mounted on the connector;

a receiver element mounted on the connector; and

an identifier element mounted on the connector and coupled to the receiver element;

directing flow of the first fluid through the conduit;

transmitting an initial beam of energy from the transmitter element into contact with the first fluid;

altering the initial beam of energy through interaction with the first fluid by absorbing, refracting and/or reflecting the beam of energy to create a first altered beam of energy, wherein the first altered beam of energy is different from the initial beam of energy;

receiving the first altered beam of energy with the receiver element; and

analyzing the first altered beam to identify the first fluid with the identifier element.

2. The method ofclaim 1 wherein analyzing the first altered beam to identify the fluid comprises comparing the first altered beam of energy with stored data associated with selected fluids to identify the first fluid.

3. The method ofclaim 1 wherein transmitting the initial beam of energy comprises transmitting a beam of infrared light or near infrared light.

4. The method ofclaim 1 further comprising:

replacing the first fluid with a second fluid;

directing flow of the second fluid through the conduit;

transmitting the initial beam of energy from the transmitter element into contact with the second fluid;

altering the initial beam of energy through interaction with the second fluid by absorbing, refracting and/or reflecting the beam of energy to create a second altered beam of energy, wherein the second altered beam of energy is different from the initial beam of energy and is different from the first altered beam of energy;

receiving the second altered beam of energy with the receiver element; and

analyzing the second altered beam to identify the second fluid with the identifier element.

5. The method ofclaim 4 wherein the initial beam of energy is not associated with the first fluid or with the second fluid.

6. The method ofclaim 1 wherein the initial beam of energy is not associated with the first fluid.

7. The method ofclaim 1 further comprising securing the device housing to skin of the user.

8. The method ofclaim 7 further comprising:

while the device housing is secured to the skin of the user, replacing the first fluid with a second fluid;

directing flow of the second fluid through the conduit;

transmitting the initial beam of energy from the transmitter element into contact with the second fluid;

altering the initial beam of energy through interaction with the second fluid by absorbing, refracting and/or reflecting the beam of energy to create a second altered beam of energy, wherein the second altered beam of energy is different from the initial beam of energy and is different from the first altered beam of energy;

receiving the second altered beam of energy with the receiver element; and

analyzing the second altered beam to identify the second fluid with the identifier element.

9. The method ofclaim 7 wherein the reservoir is a first reservoir, and wherein the method further comprises:

while the device housing is secured to the skin of the user, replacing the first reservoir with a second reservoir containing a second fluid;

directing flow of the second fluid through the conduit;

transmitting the initial beam of energy from the transmitter element into contact with the second fluid;

altering the initial beam of energy through interaction with the second fluid by absorbing, refracting and/or reflecting the beam of energy to create a second altered beam of energy, wherein the second altered beam of energy is different from the initial beam of energy and is different from the first altered beam of energy;

receiving the second altered beam of energy with the receiver element; and

analyzing the second altered beam to identify the second fluid with the identifier element.

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